Ira Glass
Sarah Erush was a pharmacist and head of the Drug Information Center at the Hospital at the University of Pennsylvania. And in that job, she had to do one of those tasks that you never heard of, but then when you hear that this job exists, you think, oh right, of course. Somebody's got to do that. Namely, when patients had a bad reaction, a surprising reaction, to the drugs that they were on, Sarah Erush was the person who was supposed to make sure that the Food and Drug Administration was notified about it. The FDA keeps track of these things, drug injuries. It's part of monitoring whether drugs are safe.

And so one day in 2002, she got this unusual call from somebody at the FDA about one of the most popular drugs in the country-- acetaminophen. Acetaminophen is the active ingredient in Tylenol. And every now and then, Erush had sent in a report about some patient reacting to acetaminophen.

Sarah Erush
And they said, we were looking at your reports on acetaminophen, and we were wondering if you had ever really sat and collated this data. And we said, no, not really. We've been reporting it all along, and we look at it when we report it. But we never really looked at it in aggregate.

Ira Glass
"In aggregate"-- they never looked at all the cases together as a group.

Sarah Erush
And they said, well, we have been looking at it in aggregate, and we think it's really interesting. And we think you might want to do that. And we thought that was kind of an odd request.

And so I said, well, why would we do that? What are you seeing? And they said, well, we don't really want to tell you that. We want to see if you think it's compelling as well.

So they sort of opened the door and said, you should go look, but they didn't tell us what to look for. Which was a really good scientific method, because they didn't tell us what we should go find, which would have biased us towards the data. They just said, you should go look. It's interesting.

Ira Glass
Sarah got off the phone and told her office-mate, the FDA wants us to look at our acetaminophen cases. And her co-worker was all, why? They had no idea.

Sarah Erush
Not a clue. We really didn't. Till we started looking at it, and then this little light bulb kind of went on in the back of our heads, where we said, hey, we do remember that one odd case.

Oh, we do remember that other odd case. Oh, we do remember that third odd case. And then it started to occur to us, we have a lot of odd cases.

Ira Glass
Sarah Erush found 23 people in four years at just one hospital who said they took just a little extra, just a few more pills than recommended for a few more days, and severely damaged their livers. Three of them died. Two had transplants.

Now most of these 23 were either chronic heavy drinkers or had a lot of alcohol around the time they were taking the pills, which makes acetaminophen more dangerous. But it wasn't every case. Some didn't report any drinking. And what surprised Sarah Erush most of all was the amounts-- just how easy it was to take too much acetaminophen.

Sarah Erush
It used to be touted as the safest pain reliever you can buy. I mean, that was the big push on selling Tylenol. It's the safest pain reliever you can buy.

And in fact, when we would interview the patients and say, you know, the label says how much to take. Why did you take more than that? And the answers were always, because it always says it's the safest thing you could buy. I figure if two were OK, then I would take three.

When we would say, you know, you realize you're here because here you have a high acetaminophen level and that's affected your liver, And they would be aghast. They would say, from Tylenol? This is from Tylenol? How could it be from Tylenol? I thought that was harmless, or it was so safe, it couldn't possibly happen.

I didn't take that much. That would be the first thing they would all say. I didn't take that much. And when you'd ask how much, it was more than the recommended dose, but they really didn't take that much more.

Ira Glass
Erush says she's also surprised how many doctors she meets who don't know this kind of reaction can happen if a patient takes just a little bit too much acetaminophen.

Sarah Erush
I am stunned and amazed, still, how physicians will almost routinely throw in Tylenol when they're treating pain. Well, here, why don't you take this on top of everything else, because it's only Tylenol. It's fine. It's safe.

My own mother, she had bone pain from cancer, and they had her on lots of big painkillers. And they said, oh, and we're going to give her 4 grams of Tylenol a day, too. And I said, why? And they said, oh, it's good for bone pain.

I said, no, it's not. [LAUGHS] A, it's not, and B, I don't want my mother taking 4 grams of Tylenol a day for no good reason whatsoever. She's also on morphine, and I think that'll probably do it.

Ira Glass
Over the last nine months, our radio show has worked alongside the investigative reporting organization ProPublica-- who's been at this even longer-- looking into acetaminophen and Tylenol, interviewing dozens of doctors and scientists. ProPublica went through hundreds of documents. And what we've concluded is that while Tylenol has built its reputation on the idea that it is safer than other over-the-counter painkillers, it is less safe than many of us believe.

Now I want to be very clear about what I'm saying here. Taken as recommended, Tylenol-- or any drug containing the active ingredient in Tylenol, acetaminophen-- is considered safe by most doctors and experts. The problems that we're talking about with the drug probably affect much less than 1% of all the people taking acetaminophen and Tylenol. After all, one out of six Americans take acetaminophen in any given week-- 50 million people, according to Tylenol's manufacturer.

And as a pharmacist, Sarah Erush says, sure, we should keep it on the market. No question. It's the best medicine out there for lots of situations. Mild chronic pain, like for geriatric patients, two Tylenol a day.

Sarah Erush
They can take that for a lot longer than they might be able to take two Motrin or Advil a day because of the risk of GI ulceration.

Ira Glass
In a pediatric hospital, she says, it's the best thing to give a kid for fever. Won't upset a stomach. It won't interact with other drugs. It doesn't put them at risk for Reye's syndrome, the way that aspirin would.

But all that said, it is very easy overdose on acetaminophen. Over 150 people in the United States die on average every year from accidentally taking too much of the drug. 150 people. That data comes from the federal government, from the Centers for Disease Control and Prevention. Federal government data also shows that every year, 78,000 people land in the emergency room and over 33,000 people are hospitalized either from intentional or unintentional overdoses of the drug.

Will Lee is one of the liver specialists and researchers who's been calling attention to the dangers of acetaminophen. He is at the University of Texas Southwestern Medical Center and talked to reporter Sean Cole.

Will Lee
In one of the articles, we actually printed up the little coupon that I got with my Zocor prescription that says, $2 off on your next acetaminophen bottle. And one of the things on the coupon, it says safest. Not safer, or not safe, but safest. Well, this is the number-one drug killing Americans every year.

Sean Cole
Over-the-counter drug killing Americans.

Will Lee
Over-the-counter drug.

Sean Cole
Not the safest.

Will Lee
Not the safest, for sure. So I guess that's-- if you think I have a bee in my bonnet, that's probably where it came from.

Ira Glass
That assessment, that acetaminophen kills more Americans than any other over-the-counter pain reliever, comes from two big databases, the Centers for Disease Control and Prevention-- that's part of the federal government-- and the American Association of Poison Control Centers. The company that makes Tylenol, McNeil Consumer Healthcare, does not agree with that assessment. A spokesperson said in an email that in their view, we here at This American Life cannot responsibly say on the radio that acetaminophen kills more people, because those two databases, quote, "simply do not contain the information needed," end quote.

And in fact, it's true that epidemiologists have pointed out that those databases might not accurately count all of the people who die as a result of taking other over-the-counter pain relievers. But that is a theoretical possibility, that lots of people may be dying from those other over-the-counter painkillers. There aren't studies-- or anyway, we couldn't find any-- which locate real people who died this way and find more of them dying from over-the-counter aspirin or ibuprofen or any of the others than die from acetaminophen. We asked McNeil for studies like that, and they did not send any.

Just last month, McNeil, the maker of Tylenol, and its parent company Johnson & Johnson, announced that they're putting a new warning onto the caps of Extra Strength Tylenol saying, in bright red letters, "Contains acetaminophen," and "Always read the label." The new warning does not go so far as to say that a relatively small overdose can kill you.

Most people already know that acetaminophen can be dangerous. According to a national poll commissioned by ProPublica and our radio program, 86% of Americans know that Tylenol can cause severe liver damage, and 2/3 of the public knows that it can kill you. But I think that many people do not know just how little extra it takes to be dangerous or to kill you. Certainly, I have say none of us who worked on this story, here at our radio show, knew this before.

And why not? Well, today we explain how we got to this point, how one of the most widely-used over-the-counter painkillers in the country, acetaminophen, also kills so many people. And many of us had no idea.

And so even though a lot of you already know that acetaminophen can be dangerous, we're going to spend an hour on this today. Because number one, over 150 people are dying every year. It seems completely unnecessary. And number two, the story of how this drug has been regulated by the Food and Drug Administration-- when we heard it, I have to say we were shocked at the government's behavior, and we think that you will be shocked.

And so from WBEZ Chicago, it's This American Life, distributed by Public Radio International. I'm Ira Glass. Our show today on all of these things. Stay with us. And I turn things over now to the reporter who's been looking into this for our radio show, Sean Cole.

 

© 2012 Chicago Public Media & Ira Glass